Clinical Trial: Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Cross-Over, Placebo-Controlled Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine

Brief Summary:

This is a Phase Ib, 12-week, multi-center, randomized, double-blind, cross-over, placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe migraine headaches (2-8 per month).

This study is designed to describe the efficacy and safety of ELS-M11 as compared to placebo.


Detailed Summary:

Achelios is developing ELS-M11 for topical application for the acute treatment of migraine events in patients with a history of migraine with or without aura.

To be eligible for the study, patients must have a one-year documented history of migraine headache (as defined by the International Headache Society IHS), with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit.

The total duration of the study is the completion of five migraine headaches per subject over a maximum 12 week period followed by a 3-14 day Follow-Up Period.


Sponsor: Achelios Therapeutics

Current Primary Outcome: Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11 [ Time Frame: 2 hours ]

Pain relief (as defined by a one point decrease on a 4 point pain intensity scale) in subjects experiencing a moderate to severe migraine headache, 2 hours after the initial application of ELS-M11.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of patients who report pain relief at various time points within a 24 hour period, following the first application of ELS-M11 [ Time Frame: 24 hours ]
    Pain relief (as defined by a one point decrease on a 0-3 point pain intensity scale) in subjects experiencing a moderate to severe migraine headache over a 24 hour period following the first application of ELS-M11.
  • Percentage of patients who report complete pain resolution within 24 hours following the first application of ELS-M11. [ Time Frame: 24 hours ]
    Complete resolution (intensity score of 0 on a 0-3 pain scale) of migraine pain within 24 hours, following ELS-M11 application in subjects experiencing a moderate to severe migraine headache.
  • Percentage of patients who report sustained pain relief after the first application of ELS-M11 [ Time Frame: 24 hours ]
    Sustained pain relief defined as pain relief by 2 hours post study medication application with no increase in the pain intensity score up to 24 hours post medication application in moderate and severe headaches, following ELS-M11 application.
  • Percentage of patients who report sustained complete pain resolution after the first application of ELS-M11. [ Time Frame: 24 hours ]
    Sustained complete pain resolution defined as pain free by 2 hours post study medication application with no change in a pain intensity score of 0 up to 24 hours post medication application in moderate and severe headaches, following ELS-M11 application.
  • Time to Initial Use of Rescue Medication following the first application of ELS-M11 [ Time Frame: 24 hours ]
    Time to Initial Use of Rescue Medication following ELS-M11 application in subjects experiencing moderate to severe headaches within a 24 hour period
  • Use of Rescue Medication following the first application of ELS-M11 by 24 hours [ Time Frame: 24 hours ]
    Use of Rescue Medication within 24 hours following ELS-M11 application in patients experiencing moderate to severe migraine headaches.
  • Resolution of migraine-associated symptoms, following the first application of ELS-M11 [ Time Frame: 24 hours ]
    Free of migraine-associated symptoms within 24 hours after ELS-M11 application in patients experiencing moderate to severe migraine headaches.
  • Percentage of patients who can resume or maintain their normal routine, following the first application of ELS-M11. [ Time Frame: 24 hours ]
    Resuming or maintaining normal routine within 24 hours after first study medication application in moderate and severe headaches.


Original Secondary Outcome: Same as current

Information By: Achelios Therapeutics

Dates:
Date Received: February 5, 2014
Date Started: March 2014
Date Completion:
Last Updated: January 23, 2015
Last Verified: November 2014